- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06132308
Evaluation of PENG Block in Terms of Block Time and Postoperative Pain
November 4, 2024 updated by: Savas Altinsoy, Diskapi Yildirim Beyazit Education and Research Hospital
Evaluation of PENG Block Applied in Hip Surgery in Terms of Block Duration and Postoperative Pain
Hip fracture is a common orthopedic emergency in the elderly and causes significant morbidity and is associated with mortality.
In most patients, surgical reduction and fixation is the definitive treatment.
Effective perioperative analgesia minimizing the need for opioids and related side effects is recommended in this patient population.
Therefore, various methods are used.
When the investigators look at the literature, for PENG block It is observed that different drug doses (20cc, 30cc, and 40cc) are used.
In this study, the investigators planned to investigate the effectiveness of PENG blocks, postoperative analgesia, and side effects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients in the ASA 1-3 group who had hip surgery with PENG block for any reason will be included in the study.
Approximately 60 patients will participate in the study, the number will be finalized as a result of power analysis.
The routine algorithm for patients who will undergo hip surgery is spinal or general anesthesia after peripheral block for postoperative analgesia.
Before the block, all patients were monitored by standard monitoring and intravenous vascular access was opened.
For PENG block, patients are in the supine position is deposited.
The convex ultrasound probe is initially placed over the anterior superior iliac spine, then the probe moves medially until the femoral artery is visualized.
In this view, iliopectineal eminence (IPE), iliopsoas muscle and tendon, femoral artery and iliac muscle are observed.
Between the psoas tendon and the IPE 22 gauge 80 mm block needle is guided and local anesthetic is administered by intermittent aspiration.
Although drug doses vary according to the patient and the surgery to be performed in our clinic, %0.25 bupivacaine is used in 20cc, 30cc and 40cc doses.
In all patients with block, 30 minutes after the block application, motor and sensory examination is carried out.
Sensory block was evaluated by cold stimulus (0 = no cold sensation, 1 = cold sensation severely reduced, 2 = cold sensation slightly decreased, 3 = normal cold sensation).
In patients who will undergo hip surgery, due to limited kidney and liver reserves opioids are often used for analgesia.
In our clinic, to reduce opioid use in this elderly patient group, preoperative nerve block method is used.
Postoperative analgesic needs of the patients will be recorded from the information in the current patient controlled analgesia device.
Demographic data of patients, surgical method and duration from the anesthesia form will be followed.
Postoperative numerical evaluation scale (NRS-numeric rating scale; 0 = no pain, 10 = excruciating pain) will be recorded.
Postoperative pain, muscle strength, block time and nausea-vomiting PACU, 4, 8, 24 hours will be recorded.
Postoperative pain treatment satisfaction of patients numerically scale (NRS, 0 = dissatisfied, 10 = extremely satisfied) and postoperative first night sleep quality at 24 hours with NRS (0= could not sleep all night, 10= slept very well) query will be recorded.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey
- university of health siences diskapi yildirim beyazit T&R hospital
-
Ankara, Turkey, 06450
- Department of Anesthesiology and Reanimation, University of Health Sciences, Diskapi Yıldırım Beyazit Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients who have undergone hip surgery with PENG block for any reason
Exclusion Criteria:
- chronic opioid users
- cognitive disorders
- written consent form haven't get
- history of relevant drug allergy
- infection of the skin at the site of needle puncture area
- coagulopathy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: PENG Block with 0.25% bupivacaine (20 cc)
For PENG block, patients are in the supine position is deposited.
The convex ultrasound probe is initially placed over the anterior superior iliac spine, then the probe moves medially until the femoral artery is visualized.
In this view, iliopectineal eminence (IPE), iliopsoas muscle and tendon, femoral artery and iliac muscle are observed.
Between the psoas tendon and the IPE 22 gauge 80 mm block needle is guided and 20cc local anesthetic used in % 0.25 bupivacaine is administered by intermittent aspiration.
|
Peng block was performed.
|
|
Experimental: PENG Block with 0.25% bupivacaine (30 cc)
For PENG block, patients are in the supine position is deposited.
The convex ultrasound probe is initially placed over the anterior superior iliac spine, then the probe moves medially until the femoral artery is visualized.
In this view, iliopectineal eminence (IPE), iliopsoas muscle and tendon, femoral artery and iliac muscle are observed.
Between the psoas tendon and the IPE 22 gauge 80 mm block needle is guided and 30cc local anesthetic used in % 0.25 bupivacaine is administered by intermittent aspiration.
|
Peng block was performed.
|
|
Experimental: PENG Block with 0.25% bupivacaine (40 cc)
For PENG block, patients are in the supine position is deposited.
The convex ultrasound probe is initially placed over the anterior superior iliac spine, then the probe moves medially until the femoral artery is visualized.
In this view, iliopectineal eminence (IPE), iliopsoas muscle and tendon, femoral artery and iliac muscle are observed.
Between the psoas tendon and the IPE 22 gauge 80 mm block needle is guided and 40cc local anesthetic used in % 0.25 bupivacaine is administered by intermittent aspiration.
|
Peng block was performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The degree of postoperative pain
Time Frame: 0 hour
|
The degree of pain will be measured with numerical rating scale (NRS).
All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
|
0 hour
|
|
The degree of postoperative pain
Time Frame: 4 hour
|
The degree of pain will be measured with numerical rating scale (NRS).
All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
|
4 hour
|
|
The degree of postoperative pain
Time Frame: 8 hour
|
The degree of pain will be measured with numerical rating scale (NRS).
All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
|
8 hour
|
|
The degree of postoperative pain
Time Frame: 24 hour
|
The degree of pain will be measured with numerical rating scale (NRS).
All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
|
24 hour
|
|
Postoperative tramadol consumption
Time Frame: 24 hour
|
total tramadol consumption in three groups will be assessed in the postoperative period
|
24 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative tramadol consumption
Time Frame: 0 hour
|
total tramadol consumption in three groups will be assessed in the postoperative period
|
0 hour
|
|
Postoperative tramadol consumption
Time Frame: 4hour
|
total tramadol consumption in three groups will be assessed in the postoperative period
|
4hour
|
|
Postoperative tramadol consumption
Time Frame: 8 hour
|
total tramadol consumption in three groups will be assessed in the postoperative period
|
8 hour
|
|
Postoperative tramadol consumption
Time Frame: 24 hour
|
total tramadol consumption in three groups will be assessed in the postoperative period
|
24 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2023
Primary Completion (Actual)
July 2, 2024
Study Completion (Actual)
August 10, 2024
Study Registration Dates
First Submitted
March 17, 2023
First Submitted That Met QC Criteria
November 13, 2023
First Posted (Actual)
November 15, 2023
Study Record Updates
Last Update Posted (Estimated)
November 5, 2024
Last Update Submitted That Met QC Criteria
November 4, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Diskapı-YB-SA-PENG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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